A Phase 2, Randomized, Observer-Blind, Dose Finding Trial to Evaluate Safety and Immunogenicity of an Investigational Pandemic Flu Vaccine

Exclusion Criteria26

• History of sensitivity to any component of trial vaccine(s)
• Recent or ongoing history of febrile illness within 72 hours of the trial injection (defined as at least 1 measured body temperature of greater than or equal to 38°C, regardless of route of measurement). Participants meeting this criterion may be rescheduled within the protocol-defined window.
• If female, is pregnant (known before or established at the time of screening), breastfeeding, or planning a pregnancy or to breastfeed
• Known or suspected immunodeficiency (including but not limited to HIV/AIDS), or immunocompromised state, as assessed by medical history, past or current laboratory studies, and/or physical examination
• Has received the following prior to any trial injection:
• a) within 14 days:
• i) Any licensed or authorized inactivated vaccines (including vaccines containing mRNA or CpG)
• b) within 28 days:
• i) Any live vaccine
• ii) Any other investigational medicinal agent
• c) within 90 days:
• i) Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs during the period starting 90 days prior to the first study vaccine administration or planned administration during the study period. (For corticosteroids, this will mean prednisone greater than or equal to 20mg/day, or equivalent.
• Inhaled, topical, and intraarticular steroids, other topical immunomodulators, and imiquimod are allowed.)
• ii)Granulocyte or granulocyte-macrophage colony-stimulating factor
• iii) Immunoglobulins or any blood products (receipt of certain monoclonal antibodies may on a case-by case basis be non-exclusionary if approved via consultation with Sponsor Medical Monitor)
• iv) Antisense oligonucleotides
• v) Drugs/investigational agents with very long half-lives (defined as greater than equal to 60 days)
• vi) Infusion of blood products
• d) At any time: DNA plasmids or other genetic therapy intended to integrate permanently into host cell
• Is undergoing chemotherapy or expected to receive chemotherapy during the trial period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
• Underlying chronic medical condition requiring ongoing followup and monitoring by a healthcare provider that might affect the immune response to vaccine (eg, diabetes mellitus, chronic kidney disease)
• Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• Current or historical autoimmune disease
• Any skin condition and/or tattoo on both arms that may interfere with the evaluation of safety at the injection site.
• Any other finding that the Investigator considers will make the participant unsuitable for the trial or unable to comply with the trial requirements